MISSION CONTROL 02 / CLINICAL TRIAL OPERATIONS

HEALTHCARE + RESEARCH OPERATIONS

From trial deviation to evidence-backed human review.

This room shows how a multi-agent system can support clinical-trial operations without pretending to be an investigator, sponsor, IRB, safety committee, or regulator. It organizes protocol evidence, site status, consent, data quality, deviations, compliance, and escalation while qualified humans retain every consequential decision.

Run clinical missionInspect agent stackRead implementation guide

01 / BUSINESS PROBLEM

A trial can look administratively complete while critical evidence is missing.

The demo focuses on a common operations problem: a visit or assessment falls outside protocol timing, and the team must determine what evidence exists, what is missing, what must be documented, and who must decide what happens next.

OUTCOME

Faster, more consistent deviation triage

Structure the evidence package before the clinical-operations team spends time chasing records manually.

CONNECTED SYSTEMS

CTMS + EDC + eTMF + protocol registry

The public room uses synthetic connectors. A production implementation would use approved, role-scoped integrations and coded participant identifiers.

FAIL-CLOSED CONDITIONS

Consent, approval, safety, traceability

Missing consent evidence, expired approval, incomplete site training, unresolved safety events, or untraceable source data stop progression.

PROTECTED ACTIONS

No autonomous trial decisions

The system cannot enroll participants, change protocol, determine medical causality, close safety events, or make official regulatory submissions.

CLINICAL OPERATIONS CONTROL ONLINESelect a system to inspect its exact responsibility

02 / GOVERNED AGENT STACK

Each system has a narrow job and a clear authority boundary.

Click a card to inspect inputs, outputs, tools, failure behavior, and the implementation repository.

SELECTED SYSTEMF36Multi-Agent Orchestrator
CONTROL PLANE

MISSION ROLE

ACTIVE PHASE
Inspect GitHub implementation ↗
INPUTS
    OUTPUTS
      TOOLS / INTERFACES
        AUTHORITY BOUNDARY

        FAILURE BEHAVIOR

        Trial event→Plan→Protocol evidence→Trial operations→Compliance→Evaluation→Safety→Qualified human review

        03 / CLINICAL MISSION CONTROL

        Run three different trial-operations cases.

        RUNTIME READYSYNTHETIC STUDY DATAFAIL-CLOSED GOVERNANCE
        CONTROL PLANEF36orchestration
        TRIAL OPSF52domain workflow
        EVIDENCEF35protocol + study records
        ASSURANCEF109 + F37 + F09compliance + eval + safety
        AUTHORITYHUMANtrial decisions
        RUN IDnot started
        STATUSREADY
        HANDOFFS0
        TOOL CALLS0
        BLOCKERS0
        MISSION EVENT TRACEselect any event

        Run a case to generate the trial-operations trace.

        EVIDENCE TELEMETRYstructured state
        Select an event from the trace.

        04 / OPERATING MODEL

        Translate governance into measurable operations capacity.

        These are editable demonstration assumptions, not a claim of guaranteed savings or clinical performance.

        CANDIDATE REVIEWSper month
        HOURS RELEASEDillustrative
        MONTHLY CAPACITY VALUEillustrative
        ANNUAL CAPACITY VALUEillustrative

        Model assumption: candidate cases average 8 minutes of qualified human review after the multi-agent package is prepared. Real performance depends on protocol complexity, integrations, evidence quality, site processes, validation, staffing, privacy controls, and sponsor requirements.

        05 / HOW A CLIENT WOULD DEPLOY THIS

        Start with operations support, not autonomous clinical authority.

        A controlled project would begin with synthetic or de-identified cases, validate protocol and deviation handling, connect approved systems, test fail-closed behavior, and only then consider a limited human-reviewed pilot.

        1

        Map protocol and authority

        Define protocol versions, approvals, decision rights, source systems, privacy boundaries, and escalation owners.

        2

        Connect read-only evidence

        Integrate CTMS, EDC, eTMF, protocol, and training evidence with least-privilege access.

        3

        Validate failure cases

        Test missing consent, stale protocol, expired approval, training gaps, source-data gaps, and safety escalation.

        4

        Human-reviewed pilot

        Use the system to prepare operations packages while qualified staff make every consequential decision.

        5

        Measure quality

        Track evidence completeness, false escalation, missed blockers, cycle time, reviewer agreement, and auditability.

        6

        Expand only with evidence

        Increase scope only after organization-specific validation, governance approval, monitoring, and rollback readiness.

        DOCUMENTATION

        Every client should understand what the agents can and cannot do.

        The shared implementation guide explains orchestration, tools, state, permissions, evidence, evaluation, safety, human gates, production architecture, and deployment stages. The clinical room also links directly to the underlying Atlas repositories so a technical team can inspect the reference implementations.

        Open the implementation guide →